This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

NCT05082428 | Completed Results

• 2 other identifiers: A3921390FinTofUC
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (7)

• Age at the Time of Diagnosis

  Participant's age at the time of ulcerative colitis diagnosis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

  At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)

• Duration of Ulcerative Colitis

  Duration of ulcerative colitis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

  At index (from data collected and analyzed retrospectively over 5 months)

• Number of Participants With Extent of Colonic Involvement According to the Montreal Classification

  Montreal classification was used to classify UC based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Index was considered as date of initiation of tofacitinib treatment for UC.

  At index (from data collected and analyzed retrospectively over 5 months)

• Mayo Score at Initiation of Tofacitinib

  Mayo score was composed of four components: rectal bleeding, stool frequency, physician (doctors) assessment of disease activity, and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.

  At index (from data collected and analyzed retrospectively over 5 months)

• Partial Mayo Score at Initiation of Tofacitinib

  Partial Mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician (doctors) assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Partial Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.

  At index (from data collected and analyzed retrospectively over 5 months)

• Number of Participants According to Endoscopic Findings Based on Histology

  Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease (Normal vascular pattern with arborization of capillaries clearly defined, or with blurring or patchy loss of capillary margins), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration). Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

  At index (from data collected and analyzed retrospectively over 5 months)

• Number of Participants According to Endoscopic Sub Score Based on Mayo Score

  Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 3 = Severe disease (spontaneous bleeding, ulceration). Mayo score was composed of four components: rectal bleeding, stool frequency, physician assessment of disease activity and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

  At index (from data collected and analyzed retrospectively over 5 months)

Secondary Outcomes (56)

• Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52

  Week 8, Week 16, Week 24 and Week 52

• Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

  Week 8, Week 16, Week 24 and Week 52

• Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

  Week 8, Week 16, Week 24 and Week 52

• Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52

  Week 8, Week 16, Week 24 and Week 52

• Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52

  Week 8, Week 16, Week 24 and Week 52

Study Arms (1)

Patients treated with Tofacitinib

Patients treated with tofacitinib for ulcerative colitis in Finland.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective non-interventional multicenter patient chart review study, collecting real world data from 21 Finnish hospital district databases and for whom data is available.

You may qualify if:

• Xeljanz (tofacitinib) usage for ulcerative colitis
• Diagnosis of ulcerative colitis (ICD-10: K51.0, K51.1, K51.2, K51.3, K51.5, K51.8, K51.9) between January 2010 and December 2021 (incident or prevalent).

You may not qualify if:

• Age \< 18 years at the start of tofacitinib use
• Use of tofacitinib before reimbursement (1.3.2019)
• \< 8 weeks of treatment with tofacitinib at the start of data mining
• History of panproctocolectomy, IPAA or ileostomy.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Helsinki, Finland

Location

Related Publications (1)

• Molander P, Kosunen M, Eronen H, Tillonen J, Karajamaki A, Heikkinen M, Punkkinen J, Mattila R, Toppila I, Holsa O, Kalpala K, Henrohn D, Af Bjorkesten CG. Tofacitinib real-world experience in ulcerative colitis in Finland (FinTofUC): a retrospective non-interventional multicenter patient chart data study. Scand J Gastroenterol. 2024 Apr;59(4):425-432. doi: 10.1080/00365521.2023.2298361. Epub 2023 Dec 29.

  PMID: 38156792 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: May 30, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)